Effect of 4-7-8 Breathıng Technıque on Shoulder Paın and Respıratory Functıon Tests After Laparoscopıc Cholesectectomy

Not Applicable

Not yet recruiting

• Conditions: Laparoscopic Cholecystectomy; Breathing Exercise; Pulmonary Function Test; Shoulder Pain; 4-7-8 Breathing Technique; Surgical Nursing
• Interventions: Other: 4-7-8 Breathing Technique

• Registration Number: NCT06415890
• Lead Sponsor: Mustafa Kemal University

Brief Summary

This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after laporoscopic cholecystectomy. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods.

Detailed Description

Laporoscopic cholecystectomy (LC) is the most commonly used method for the treatment of cholecystitis, one of the most common diseases of the digestive system. In addition to its advantages such as low risk of complications and usually requiring less than 24 hours of hospitalization, shoulder pain develops in approximately 35-80% of patients after LC. After LK, patients' lungs may be affected due to factors such as intraoperative general anesthesia, mechanical ventilation support, carbon dioxide (CO2) pneumoperitoneum administration, anesthetic drugs and patient positioning, and patients experience shoulder pain, especially with CO2 pneumoperitoneum administration. In patients undergoing LK, shoulder pain felt throughout the thorax causes spasm and restriction of movement in the muscles assisting respiration and an increase in intercostal tone. This leads to a decrease in the amount of air filling the lungs, accumulation of secretions, pneumonia, decreased functional residual volume and increased risk of atelectasis. For this reason, it is necessary to evaluate the respiratory system in patients undergoing LK as in all surgical interventions and to monitor pulmonary functions (FVC, FEV1, FEV1/FCV) to evaluate the deterioration in lung functions and to control pain with pharmacologic and non-pharmacologic methods. One of the respiratory exercises that nurses can apply independently in the removal of CO₂, improvement of respiratory functions and pain control after surgery is the 4-7-8 breathing technique. This technique has been proven to have positive contributions in pain control, and its easy application, reliability and non-invasiveness make its use widespread.

This study was planned as a randomized controlled clinical trial to determine the effect of 4-7-8 breathing technique on shoulder pain and pulmonary function tests after LK. A sample of 96 patients will be randomly assigned to the study and control groups. The study group will be administered the 4-7-8 breathing technique after LK, while the control group will be given routine care of the ward. Shoulder pain and pulmonary function tests will be measured in the first 24 hours and at discharge. The data obtained will be analyzed by appropriate statistical methods.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-17
• Study Start: 2024-07-15
• Primary Completion: 2025-04-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Undergoing elective laparoscopic cholecystectomy,
• Admitted to the clinic at least 2 hours before the surgical procedure,
• Open to communication and cooperation,
• Written and verbal permission to participate in the study was obtained,
• Conscious, oriented and cooperative,
• No cognitive and mental problems,
• Speaks and understands Turkish,
• American Society of Anesthesiologists (ASA) classification scores of I and II,
• Hospitalized at least one night after surgical intervention,
• Patients aged 18 years and older will be included in the study.

Exclusion Criteria

• Undergoing emergency laparoscopic cholecystectomy,
• Open cholecystectomy,
• Not admitted to the clinic at least 2 hours before the surgical procedure,
• Not open to communication and cooperation,
• Written and verbal permission to participate in the research could not be obtained,
• Unconscious, disoriented and uncooperative,
• Cognitively and mentally impaired,
• Speaking Turkish but not understanding it,
• Discharged on the same day after surgical intervention,
• ASA score III and above,
• Patients aged 18 years and younger will not be included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathing Exercise Group	4-7-8 Breathing Technique	In addition to the routine treatment and care practices of the clinic, the patients included in the study group will be taught the 4-7-8 breathing technique by the researcher and applied after surgery. They will be provided to complete one set (4 breaths) by practicing the 4-7-8 breathing technique first with the researcher and then alone. The training will last approximately 15 minutes for each patient. Patients will be asked to start the first breathing exercise at the 4th hour after coming to the clinic after laparoscopic cholecystectomy and perform one set (4 breaths) every two hours.

Primary Outcome Measures

Name	Time	Method
Shoulder Pain	Second postoperative day	Visual Analog Scale (VAS):The VAS used in this study is a one-dimensional pain scale commonly used in adult populations. The VAS is a continuous scale consisting of a horizontal or vertical line 10 centimeters (100 mm) long. Pain intensity is determined by statements ranging from "no pain" at one end of the scale to "excruciating pain" at the other end. The participant is asked to place a line perpendicular to the VAS line at the point representing pain intensity. Pain scoring is determined by measuring the distance (mm) on the 10-centimeter line using a ruler and is defined by providing a score range between 0-100 mm (No pain=0-4 mm, mild pain=5-44 mm, moderate pain=45-74 mm and severe pain=75-100 mm). In this study, the vertical form of the VAS will be used to evaluate shoulder pain in patients after surgical intervention based on the information that the vertical form of the VAS gives more accurate results than the horizontal form; Translated with DeepL.com (free version)
Pulmonary Function Test	Second postoperative day	Pulmonary Function Test: Pulmonary function values will be evaluated with a portable . FVC (%), FEV1 (%) and FEV1/FVC (%) parameters will be used in the evaluationpulmonary function test device.

Trial Locations

Locations (1)

İskenderun Devlet Hastanesi; 🇹🇷 Hatay, Turkey